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Mass Screening With Low-Dose CT for Lung Cancer in Guangzhou

Primary Purpose

Lung Cancer

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Low-dose computed tomography
Sponsored by
The First Affiliated Hospital of Guangzhou Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Lung Cancer focused on measuring Screening

Eligibility Criteria

40 Years - 74 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Minimum age of 40 years among the residents in Guangzhou

Exclusion Criteria:

  • Persons who had a diagnosis of lung cancer or treatment-related to lung cancer with the past 5 years

Sites / Locations

  • The First Affiliated Hospital of Guangzhou Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Screening group

Arm Description

Outcomes

Primary Outcome Measures

The incidence of lung cancer
The incidence of lung cancer among the overall people in the screening

Secondary Outcome Measures

The incidence of lung cancer among people with high-risk factors
The incidence of lung cancer among people with high-risk factors
The incidence of lung cancer among people with non-high-risk factors
The incidence of lung cancer among people with non-high-risk factors
High risk factors associated with lung cancer (by questionnaire)
Every participant has to complete a questionnaire before undergoing an LDCT examination. Univariate analysis and multivariate logistic regression analyses will be performed to determine the high risk factors associated with lung cancer
Cost-effectiveness ratio (costs of examinations, diagnoses, and treatments)

Full Information

First Posted
June 12, 2021
Last Updated
March 22, 2022
Sponsor
The First Affiliated Hospital of Guangzhou Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04938804
Brief Title
Mass Screening With Low-Dose CT for Lung Cancer in Guangzhou
Official Title
Mass Screening With Low-Dose CT for Lung Cancer in Guangzhou
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2015 (Actual)
Primary Completion Date
December 1, 2025 (Anticipated)
Study Completion Date
December 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital of Guangzhou Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
A single-arm, prospective study to explore the incidence of lung cancer, the high-risk factor of lung cancer, and the cost-effectiveness of early screening of lung cancer in the general population over 40 years old with low-dose computed tomography in Guangzhou, China

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
Screening

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Screening group
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Low-dose computed tomography
Intervention Description
The Low-dose computed tomography is conducted according to the guideline suggested by American College of Radiology.
Primary Outcome Measure Information:
Title
The incidence of lung cancer
Description
The incidence of lung cancer among the overall people in the screening
Time Frame
11 years
Secondary Outcome Measure Information:
Title
The incidence of lung cancer among people with high-risk factors
Description
The incidence of lung cancer among people with high-risk factors
Time Frame
11 years
Title
The incidence of lung cancer among people with non-high-risk factors
Description
The incidence of lung cancer among people with non-high-risk factors
Time Frame
11 years
Title
High risk factors associated with lung cancer (by questionnaire)
Description
Every participant has to complete a questionnaire before undergoing an LDCT examination. Univariate analysis and multivariate logistic regression analyses will be performed to determine the high risk factors associated with lung cancer
Time Frame
11 years
Title
Cost-effectiveness ratio (costs of examinations, diagnoses, and treatments)
Time Frame
11 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Minimum age of 40 years among the residents in Guangzhou Exclusion Criteria: Persons who had a diagnosis of lung cancer or treatment-related to lung cancer with the past 5 years
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wenhua Liang, MD
Phone
+86-02-83062808
Email
liangwh1987@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wenhua Liang, MD
Organizational Affiliation
The First Affiliated Hospital of Guangzhou Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenhua Liang, MD
Phone
+86-02-83062808
Email
liangwh1987@163.com

12. IPD Sharing Statement

Learn more about this trial

Mass Screening With Low-Dose CT for Lung Cancer in Guangzhou

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